MAUDE Adverse Event Report: INOGEN INC. INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR

Model Number	IO-501
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Codes	Dyspnea (1816); Low Oxygen Saturation (2477)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
B3 date of event is estimated.The unit was not returned for evaluation.
Event or Problem Description
It was reported that the patient's unit displayed an error message and troubleshooting did not resolve the issue.As a result, the unit was not producing enough oxygen and it caused the patient to have shortness of breath and low oxygen.The patient made it back home where they were able to use their stationary concentrator without further intervention.A replacement unit was sent to the patient.

• Brand Name: INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR
• Common Device Name: INOGEN ROVE 6 PORTABLE OXYGEN CONCENTRATOR
• Manufacturer (Section D): INOGEN INC.; 600 shiloh rd; plano TX 75074
• Manufacturer (Section G): INOGEN INC.; 600 shiloh rd; plano TX 75074
• Manufacturer Contact: greg porter ; 600 shiloh rd; plano, TX 75074
• MDR Report Key: 25678352
• Report Number: 3004672275-2026-00183
• Device Sequence Number: 9656753
• Product Code: CAW
• UDI-Device Identifier: 00817131020513
• UDI-Public: (01)00817131020513
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K230052
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: IO-501
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/15/2026
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown